Department of Pathology, The Johns Hopkins Hospital, Baltimore, Maryland, USA.
Dana Farber/Brigham and Women's Cancer Center, Boston, Massachusetts, USA.
Cytopathology. 2024 Nov;35(6):695-705. doi: 10.1111/cyt.13423. Epub 2024 Aug 1.
The risk of malignancy (ROM) remains an area of interest for further evaluation in reporting systems including in International System for reporting serous fluid cytopathology (TIS), which is a standardized system for reporting effusion cytology. Herein, we report our findings in further investigation of ROM in TIS by studying on paired pleural effusion specimens and corresponding pleural biopsies with emphasis on negative for malignancy, and atypia of undetermined significance categories.
The Johns Hopkins Hospital pathology database was retrospectively searched for patients with a pleural biopsy (PBX) and a paired pleural effusion (PF) cytology specimens over a 4-year period. We employed the TIS categories. The following statistical parameters were evaluated: sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and ROM.
A total of 223 patient cases were included. Effusions TIS reclassification and ROM were as follows: 1.8% non-diagnostic (ROM 75%), 75.8% negative for malignancy (ROM 23%), 4.9% atypical cells of undetermined significance (ROM 45%), 2.2% suspicious for malignancy (ROM 80%), and 15.2% malignant (ROM 100%). Overall accuracy, sensitivity, specificity, PPV and NPV were calculated and were 79.4%, 45%, 97.7%, 91.2% and 77%, respectively. Among, discordant cases diagnosed negative for malignancy on PF and positive for malignancy on PBX, there were significant number of lymphomas, mesotheliomas, and sarcomas. Lung cancer was the most common carcinoma; however, rare types of carcinomas were noted. Cells blocks and immunohistochemistry (IHC) studies were utilized to confirm either malignant conditions or rule out malignancy in both cell blocks and histology biopsies.
This study demonstrates the high specificity and ROM for 'malignant' and 'suspicious for malignancy' categories in the TIS reporting system and highlights the modest negative predictive value for the 'negative for malignancy' category. Although Tissue biopsies are usually considered as 'gold standard', any definitive diagnosis of malignancy of body fluid should be considered positive for malignancy in further clinical decision-making.
在包括国际浆膜腔液细胞学报告系统（TIS）在内的报告系统中，恶性肿瘤风险（ROM）仍然是进一步评估的一个关注点，TIS 是一种用于报告渗出液细胞学的标准化系统。在此，我们通过研究配对的胸腔积液标本和相应的胸膜活检，进一步探讨了 TIS 中的 ROM，重点是针对恶性肿瘤和意义未明的非典型细胞为阴性的病例。
回顾性检索约翰霍普金斯医院病理学数据库，查找在过去 4 年中进行过胸膜活检（PBX）和配对胸腔积液（PF）细胞学检查的患者。我们采用了 TIS 分类。评估了以下统计参数：敏感性、特异性、阳性预测值（PPV）、阴性预测值（NPV）和 ROM。
共纳入 223 例患者。胸腔积液 TIS 再分类和 ROM 如下：1.8%为非诊断性（ROM 为 75%），75.8%为恶性肿瘤阴性（ROM 为 23%），4.9%为意义未明的非典型细胞（ROM 为 45%），2.2%为可疑恶性（ROM 为 80%），15.2%为恶性（ROM 为 100%）。总体准确率、敏感性、特异性、PPV 和 NPV 分别计算为 79.4%、45%、97.7%、91.2%和 77%。在 PF 诊断为恶性肿瘤阴性而 PBX 诊断为恶性肿瘤阳性的不一致病例中，存在大量的淋巴瘤、间皮瘤和肉瘤。肺癌是最常见的癌，但也有罕见类型的癌。细胞块和免疫组织化学（IHC）研究用于确认细胞块和组织活检中是否存在恶性情况或排除恶性。
本研究表明，TIS 报告系统中的“恶性”和“可疑恶性”类别具有很高的特异性和 ROM，而“恶性肿瘤阴性”类别的阴性预测值较低。尽管组织活检通常被认为是“金标准”，但在进一步的临床决策中，任何体液恶性肿瘤的明确诊断都应被视为阳性。
